Factors Influencing Pediatric Asthma

Asthma in Children Clinical Trial

— FIPA  

Official title:

Factors Influencing Pediatric Asthma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03302962
• Other study ID #: 1U54MD008164-01
• Status: Completed
• Phase: N/A
• First received: September 29, 2017
• Last updated: October 4, 2017
• Start date: March 14, 2013
• Est. completion date: May 25, 2017

Study information

• Verified date: October 2017
• Source: Missouri Breaks Industries Research, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Asthma is a chronic lung disease with serious morbidity and potential mortality. Multiple physiologic, environmental and social conditions impact the prevalence and severity of asthma. Even when diagnosed, effective control can be impeded by improper use of medication, not understanding or being unable to avoid environmental triggers, lack of continuity in follow-up care, and lack of an asthma action plan. American Indians are especially at-risk for health problems related to asthma. American Indians have the highest asthma rate among single-race groups; 18.5% of American Indians are diagnosed with asthma, while only 11% are diagnosed with asthma in the general population but little is known about why this is true. Asthma is a prototypic example of the interaction of biologic, environmental and psychosocial influences on disease and this study investigated the possible improvement in asthma control from an intensive educational intervention.

Description:

The primary aim of this study was to test the hypothesis that intensive patient education regarding self-directed, stepped care will result in reduced morbidity and medical care utilization, while increasing quality of life.

One half (54) of the identified cases will be randomized to receive the previously established "BREATHE" study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 324
• Est. completion date: May 25, 2017
• Est. primary completion date: May 25, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 17 Years

Eligibility

Inclusion Criteria:

• Cases must be "American Indian" (eligibile for care within the Indian Health Service); and at least 2 of the following 3 criteria:

1. a diagnosis of asthma on at least 2 occasions by more than one provider during the past 2 years.

2. refills of asthma treatment medications on at least 2 occasions during the past 2 years.

3. Improvement of spirometry FEV1 of 20% with use of albuterol MDI or nebulizer.

• Controls meet the same demographic criteria as cases, but must also meet all of the following criteria.

1. No diagnosis of asthma by any provider during the past 2 years.

2. No prescriptions of any asthma meds during the past 2 years.

3. FEV1 on spirometry greater than 80% of predicted value Exclusion Criteria:

Exclusion Criteria:

1. Birthweight less than 2500 grams

2. Neonatal ventilator treatment

3. Hospitalization at birth greater than 15 days.

4. Congenital heart anomaly requiring surgery

5. Diagnosis of cystic fibrosis

6. Congenital lung, diaphragm, chest wall, or airway anomaly

7. Diagnosis of pneumonia, pertussis, or tuberculosis within the past year

8. Congenital muscular disorder

Related Conditions & MeSH terms

• Asthma
• Asthma in Children

Intervention

Behavioral:
• Intensive Asthma Education
One half (54) of the identified cases were randomized to receive the previously established "BREATHE" study educational program, emphasizing patient-centered, self management of asthma. Periodic follow-up through personal contact and surveillance of IHS RPMS or other medical provider records was conducted.

Locations

Country	Name	City	State
United States	Missouri Breaks Industries Research Inc.	Eagle Butte	South Dakota

Sponsors (2)

Lead Sponsor	Collaborator
Missouri Breaks Industries Research, Inc.	Sanford Research

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Chart Review of ED Visits	Emergency room visits for pulmonary complaints	3 years